The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx Velocity™ on patient outcome at one month.
This is a prospective, non-randomized, multi-center trial. Patients will be treated with the AngioGuard™ device and Bx Velocity™ stent and will be followed for six-months post-procedure.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
AngioGuard™ device and Bx Velocity™ stent
Herzzentrum Siegburg GMBH
Siegburg, Germany
clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent
Time frame: 1 month
successful placement and retrieval without embolic occlusions of vessels distal to the position of the device
Time frame: post-procedure
overall survival rates
Time frame: 1 month and 6 months
device evaluation
Time frame: post-procedure
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